RecruitingPhase 3NCT06858111

Fertilo In Vitro Research Study and Trial

Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)


Sponsor

Gameto, Inc.

Enrollment

500 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm. * Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. * Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Fertilo and a medical device called Medicult IVM for people with in vitro maturation of oocytes. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFertilo

Fertilo is an engineered line of ovarian support cells that aid egg maturation.

DEVICEMedicult IVM

MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.


Locations(13)

Women's Specialty & Fertility Center

Clovis, California, United States

HRC Fertility

Encino, California, United States

Florida Fertility Institute

Clearwater, Florida, United States

IVF Florida

Pembroke Pines, Florida, United States

Shady Grove Fertility

Rockville, Maryland, United States

Columbia University Fertility Center

New York, New York, United States

Reach Fertility

Charlotte, North Carolina, United States

Conceptions Fertility

Raleigh, North Carolina, United States

Care Fertility

Bedford, Texas, United States

Dallas Fort Worth Fertility Associates

Dallas, Texas, United States

Aspire Fertility San Antonio

San Antonio, Texas, United States

Shady Grove Houston

Webster, Texas, United States

Utah Fertility Center

Pleasant Grove, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06858111


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